Delving into the Latest Updates on DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine

Synonyms

Zilbrix-Hib

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersRespiratory Diseases+ [1]

Active Indication-

Inactive Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Start Date18 Jun 2008

Sponsor / Collaborator

GSK Plc

NCT00473668

/ CompletedPhase 3

Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jun 2007

Sponsor / Collaborator

GSK Plc

NCT00332566

/ CompletedPhase 3

Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jun 2006

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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2

Literatures (Medical) associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

01 Apr 2008·Expert Opinion on Biological TherapyQ3 · MEDICINE

Clinical experience with DTPw-HBV and DTPw-HBV/Hib combination vaccines

Q3 · MEDICINE

Review

Author: Stanislav Plisek ; Roman Prymula

BACKGROUNDCombined diphtheria-tetanus-whole-cell pertussis (DTPw) vaccines remain the cornerstone of many childhood vaccination programs. Larger DTPw-based combination vaccines facilitate high coverage and protection against other childhood pathogens, such as hepatitis B (HBV) and Haemophilus influenzae type b (Hib). Such vaccines have been available since the mid-1990s (Tritanrix-HBV and Tritanrix-HBV/Hib; GlaxoSmithKline [GSK] Biologicals), demonstrating excellent immunogenicity in various schedules. In order to address growing demand for DTPw-based vaccines, GSK Biologicals have developed the Zilbrix range using a new DTPw antigen source and containing reduced quantities of polyribosylribitol phosphate [PRP].OBJECTIVEThis article presents clinical trial results for both DTPw-based vaccines.METHODSGSK Biologicals provided a comprehensive data package, which was supplemented with a Medline literature search.CONCLUSIONNew antigen sources and reduced PRP will ensure the continued supply of DTPw-based combination vaccines for vital global mass vaccination campaigns.

PLOS ONEQ3 · CROSS-FIELD

HIV-Infected or -Exposed Children Exhibit Lower Immunogenicity to Hepatitis B Vaccine in Yaoundé, Cameroon: An Appeal for Revised Policies in Tropical Settings?

Q3 · CROSS-FIELD

ArticleOA

Author: Njom Nlend, Anne Esther ; Tchidjou, Hyppolite Kuekou ; Penlap, Véronique ; Pieme, Constant Anatole ; Ngounouh, Christian Taheu ; Nguwoh, Philippe Salomon ; Moyou, Roger Somo ; Colizzi, Vittorio ; Fokam, Joseph ; Otélé, Jean Mbede

BACKGROUNDSince 2005, anti-hepatitis B virus (anti-HBV) vaccine is part of the Expanded Program on Immunization (EPI) for infants born in Cameroon, with 99% anti-HBV coverage. In a context of generalized HIV epidemiology, we assessed paediatric anti-HBV vaccine response according to HIV status, feeding option and age in a tropical context.METHODOLOGYProspective, observational and cross-sectional study conducted among 82 children (27 [IQR: 9-47] months, min-max: 6-59), after complete anti-HBV vaccination (Zilbrix Hepta: 10μg AgHBs) at the Essos Health Centre in Yaounde, Cameroon, classified as group-A: HIV unexposed (28), group-B: HIV-exposed/uninfected (29), group-C: HIV-infected (25). Quantitative anti-HBs ELISA was interpreted as "no", "low-" or "protective-response" with <1, 1-10, or ≥10 IU/L respectively; with p-value<0.05 considered significant.RESULTSChildren were all HBV-unexposed (AcHBc-negative) and uninfected (HBsAg-negative). Response to anti-HBV vaccine was 80.49% (66/82), with only 45.12% (37/82) developed a protective-response (≥10IU/L). According to HIV status, 60.71% (17/28) developed a protective-response in group-A, vs. 51.72% (15/29) and 20% (5/25) in group-B and group-C respectively, Odds Ratio (OR): 2.627 [CI95% 0.933-7.500], p = 0.041. According to feeding option during first six months of life, 47.67% (21/45) developed a protective-response on exclusive breastfeeding vs. 43.24% (16/37) on mixed or formula feeding, OR: 1.148 [CI95% 0.437-3.026], p = 0.757. According to age, protective-response decreased significantly as children grow older: 58.33% (28/48) <24 months vs. 26.47% (9/34) ≥24 months, OR: 3.889 [CI95% 1.362-11.356], p = 0.004; and specifically 67.65% (23/34) ≤6 months vs. 0%, (0/5) 33-41 months, p = 0.008.CONCLUSIONSAnti-HBV vaccine provides low rate of protection (<50%) among children in general, and particularly if HIV-exposed, infected and/or older children. Implementing policies for early vaccination, specific immunization algorithm for HIV-exposed/infected children, and monitoring vaccine response would ensure effective protection in tropical settings, pending extensive/confirmatory investigations.

100 Deals associated with DTPw-HBV/Hib Kft vaccine(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 3	NI	GSK Plc	01 Jun 2006
Diphtheria	Phase 3	AR	GSK Plc	01 Jun 2006
Haemophilus Infections	Phase 3	NI	GSK Plc	01 Jun 2006
Haemophilus Infections	Phase 3	AR	GSK Plc	01 Jun 2006
Hepatitis B	Phase 3	NI	GSK Plc	01 Jun 2006
Hepatitis B	Phase 3	AR	GSK Plc	01 Jun 2006
Tetanus	Phase 3	AR	GSK Plc	01 Jun 2006
Tetanus	Phase 3	NI	GSK Plc	01 Jun 2006
Whooping Cough	Phase 3	NI	GSK Plc	01 Jun 2006
Whooping Cough	Phase 3	AR	GSK Plc	01 Jun 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00678301 (CTgov)	Phase 3	Streptococcal Infections	365	GSK Biologicals' Synflorix™+GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Synflorix™ + Zilbrix™ Hib + Polio Sabin™)	amnnwgdhcb(rmzmzvlrur) = expqhdvveh gigkfaczut (vlwvxllvbg, qodjsguklm - rgfzqxgvbv) View more	-	27 Oct 2017
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	amnnwgdhcb(rmzmzvlrur) = xqimunhqhj gigkfaczut (vlwvxllvbg, qfnhsdbgnj - gbphckkfur) View more
NCT00473668 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	300	Zilbrix-Hib (Tritanrix-HepB/Hiberix Kft. Group)	mfxusxyaeg(kshouinopp) = cbautrchsg afigwiodss (nyideokwxl, tqfgvvqgbm - sjspyzxlee) View more	-	18 Aug 2017
				Tritanrix™-HepB+Hiberix™ (Tritanrix-HepB/Hiberix LD Group)	mfxusxyaeg(kshouinopp) = lwxlypkbpy afigwiodss (nyideokwxl, smflxhhgyn - xppcvmbuta) View more
NCT00473668 (Pubmed \| BMC Infect Dis)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	299	DTPw-HBV/Hib vaccine (DTPw-HBV/Hib2.5 [Kft])	jdgqbgxueh(ibijzknnqq) = mamryqntur qvehjndpis (myytrmaseo ) View more	Positive	15 Oct 2010
				DTPw-HBV/Hib vaccine (DTPw-HBV/Hib)	jdgqbgxueh(ibijzknnqq) = annaatubmt qvehjndpis (myytrmaseo ) View more